Non-invasive determination of direction and rate of change of an analyte

• US 7,016,713 B2
• Filed: 01/08/2004
• Issued: 03/21/2006
• Est. Priority Date: 08/09/1995
• Status: Expired due to Fees

• Current Assignee: Inlight Solutions, Inc.
• Original Assignee: Inlight Solutions, Inc.
• Inventors: Gruner, William, Ridder, Trent D., Gardner, Craig M.
• Primary Examiner(s): Winakur, Eric F.
• Application Number:
  US10/753,506
• Publication Number:
  US 20040167382A1
• Time in Patent Office: 803 Days
• Field of Search: 600/310, 600/314, 600/322, 600/323, 600/336, 600/316
• US Class Current: 600/310
• CPC Class Codes: A61B 2560/0233 Optical standards
• CPC Class Codes: A61B 2562/146 for optical coupling
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• CPC Class Codes: A61B 5/0075 by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy A61B5/0071 takes precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1491 Heated applicators

Abstract

The present invention relates generally to a non-invasive method and apparatus for measuring a fluid analyte, particularly relating to glucose or alcohol contained in blood or tissue, utilizing spectroscopic methods. More particularly, the method and apparatus incorporate means for detecting and quantifying changes in the concentration of specific analytes in tissue fluid. Also, the method and apparatus can be used to predict future levels of analyte concentration either in the tissue fluid or in blood in an adjacent vascular system.

Claims

1. A method for non-invasive determination of a characteristic of change in an analyte property in a first tissue compartment, comprising:

a. irradiating the first tissue compartment;

b. measuring a signal from the first tissue compartment to acquire a first output signal;

c. after a first time interval, measuring a signal from the first tissue compartment to acquire a second output signal;

d. determining a characteristic of change of the analyte property in the first tissue compartment from the first and second output signals; and

determining a first analyte property in the first tissue compartment, and determining a second analyte property in a second tissue compartment from the first analyte property and the characteristic of change.

2. The method of claim 1, wherein the property is the analyte'"'"'s concentration.

3. The method of claim 1, wherein the characteristic comprises the rate of change, the direction of change, or a combination thereof.

4. The method of claim 1, wherein the analyte is glucose.

5. The method of claim 1, wherein the analyte is urea.

6. The method of claim 1, wherein the analyte is a controlled substance.

7. The method of claim 1, wherein the first tissue compartment comprises interstitial fluid.

8. The method of claim 1, further comprising increasing the change in the analyte property.

9. A method for non-invasive determination of a characteristic of change in an analyte property in a first tissue compartment, comprising:

a. irradiating the first tissue compartment;

b. measuring a signal from the first tissue compartment to acquire a first output signal;

c. after a first time interval, measuring a signal from the first tissue compartment to acquire a second output signal;

d. determining a characteristic of change of the analyte property in the first tissue compartment from the first and second output signals; and

f. determining a characteristic of change in an analyte property in a second tissue compartment from the characteristic of change in the first tissue compartment.

10. A method for non-invasive determination of a characteristic of change in an analyte property in a first tissue compartment, comprising:

a. irradiating the first tissue compartment;

b. measuring a signal from the first tissue compartment to acquire a first output signal;

c. after a first time interval, measuring a signal from the first tissue compartment to acquire a second output signal;

d. determining a characteristic of change of the analyte property in the first tissue compartment from the first and second output signals;

wherein the analyte is alcohol.

11. The method of claim 10, further comprising determining a first value of an analyte property in the first tissue compartment, and determining a second value of the analyte property in the first tissue compartment from the first value and the characteristic of change.

12. The method of claim 10, further comprising determining a first value of an analyte property, which first property comprises at least one of:

an analyte property in the first tissue compartment, and an analyte property in a second tissue compartment, and determining a second value of the analyte property from the first value and the characteristic of change.

13. The method of claim 10, wherein the step of irradiating the tissue comprises providing light incident on a first side of the tissue and the steps of measuring a signal comprise receiving light exiting the tissue on a second side of the tissue.

14. The method of claim 10, wherein the step of irradiating the tissue comprises providing light incident on a first side of the tissue and the steps of measuring a signal comprise receiving light exiting the tissue on the first side of the tissue.

15. The method of claim 10, further comprising after a second time interval, measuring a signal from the tissue to acquire a third output signal, and wherein determining a characteristic of change comprises determining a characteristic of change of the analyte property from the first, second, and third output signals.

16. A method as in claim 10, wherein

a. the characteristic of change in an analyte property comprises change in concentration of the analyte;

and

b. measuring a signal comprises capturing radiation at a plurality of selected frequencies emanating from the tissue at a first time and a second time.

17. The method of claim 16, further including the step of providing means for accelerating changes in concentration of the analyte in the tissue during the interval between the first and second times.

18. The method of claim 16, further including the step of determining a present concentration of the analyte in a second tissue compartment from the captured radiation.

19. A method for non-invasive determination of a characteristic of change in an analyte property in a first tissue compartment, comprising:

a. irradiating the first tissue compartment;

b. measuring a signal from the first tissue compartment to acquire a first output signal;

c. after a first time interval, measuring a signal from the first tissue compartment to acquire a second output signal;

d. determining a characteristic of change of the analyte property in the first tissue compartment from the first and second output signals;

wherein determination of a characteristic of change in an analyte property comprises determination of a characteristic of change in more than one analyte.

20. A method for non-invasive determination of a characteristic of change in an analyte property in a first tissue compartment, comprising:

a. irradiating the first tissue compartment;

b. measuring a signal from the first tissue compartment to acquire a first output signal;

c. after a first time interval, measuring a signal from the first tissue compartment to acquire a second output signal;

d. determining a characteristic of change of the analyte property in the first tissue compartment from the first and second output signals

wherein the first tissue compartment comprises blood.

21. An apparatus for determining a direction and rate of change in concentration of an analyte in tissue comprising:

a. energy means for irradiating a first tissue compartment in the tissue;

b. output means for measuring a signal from the tissue; and

c. determination means for determining the direction and rate of change in concentration of the analyte in the tissue;

wherein the determination means includes differentiation means for performing the mathematical function of differentiation upon at least one selected frequency of the optical signal over time.

22. A method for non-invasive determination of a characteristic of change in an analyte property in a first tissue compartment, comprising:

a. irradiating the first tissue compartment;

b. measuring a signal from the first tissue compartment to acquire a first output signal;

c. after a first time interval, measuring a signal from the first tissue compartment to acquire a second output signal;

d. determining a characteristic of change of the analyte property in the first tissue compartment from the first and second output signals;

wherein

e. the characteristic of change in an analyte property comprises change in concentration of the analyte; and

f. measuring a signal comprises capturing radiation at a plurality of selected frequencies emanating from the tissue at a first time and a second time; and

further including the step of providing means for accelerating equilibration of the concentration of the analyte in a first tissue compartment to a concentration of the analyte in a second tissue compartment.

23. A method for non-invasive determination of a characteristic of change in an analyte property in a first tissue compartment, comprising:

a. irradiating the first tissue compartment;

b. measuring a signal from the first tissue compartment to acquire a first output signal;

c. after a first time interval, measuring a signal from the first tissue compartment to acquire a second output signal;

d. determining a characteristic of change of the analyte property in the first tissue compartment from the first and second output signals;

wherein

e. the characteristic of chance in an analyte property comprises change in concentration of the analyte; and

f. measuring a signal comprises capturing radiation at a plurality of selected frequencies emanating from the tissue at a first time and a second time;

further including the steps of;

g. determining a set of acceptable combinations of present analyte concentration, direction of change, and rate of change of analyte concentration;

h. determining whether the present analyte concentration, direction of change, and rate of change are within the set of acceptable combinations,

i. generating a signal indicative of whether the present analyte concentration, direction of change, and rate of change are within the set of acceptable combinations.